Report of Regional Workshop on Influenza Vaccines
SEA-Immun-69
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Report of Regional Workshop on Influenza Vaccines
WHO-SEARO, New Delhi, 2–4 April 2012
Regional Office for South-East Asia
©World Health Organization 2012
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Printed in India
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Report of Regional Workshop on Influenza Vaccines
Contents
Page
Abbreviations
Executive Summary
1.Introduction
2.Proceedings of the regional workshop
3.Conclusion and recommendations
Annexes
1.List of participants
2.Programme
3.Address by Dr Samlee Plianbangchang, Regional Director,
WHO South-East Asia
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Abbreviations
AEFIAdverse events following immunization
DPRKDemocratic People’s Republic of Korea
EMREmergency medical relief
EPIExpanded programme of Immunization
GAPGlobal Action Plan
GISNGlobal Influenza Surveillance Network
GISRSglobal influenza surveillance and response system
HQHeadquarters
HPVHuman Papilloma Virus
ILIinfluenza-like Illness
IEDCRInstitute of Epidemiology, disease control and research
IECInformation, education and communication
NCIPNational Committee on Immunization Practice
NICnational influenza centres
NIPPRPnational influenza pandemic preparedness and response plans
NIPVDPnational influenza pandemic vaccine deployment plan
NRAnational regulatory authority
NTAGINational Technical Advisory Group of Immunization
PIPpandemic influenza preparedness
SARISevere Acute Respiratory Illness
SEASouth-East Asia
SMTAStandard Material Transport Agreement
SOPstandard operative procedures
VPDvaccine-preventable diseases
WHAWorld Health Assembly
WHOWorld Health Organization
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Executive Summary
A regional workshop on influenza vaccines was held at the WHO Regional office for South-East Asia in New Delhi on 2-4 April 2012. The objective of the workshop was to strengthen efficient deployment of pandemic influenza vaccines and review feasibility of introducing seasonal influenza vaccines in Member States of the South-East Asia Region. All countries in the Region had identified pandemic influenza vaccine deployment as a major response strategy to an influenza pandemic in their pandemic preparedness and response plans.Nine countries in the Region either procured or received pandemicinfluenza vaccines from WHO and eight countries deployed pandemic influenza vaccines during the influenza A/H1N1 (2009) pandemic.
In the first session after presentations on the global and regional experiencesof pandemic vaccine deployment, all Member States shared their experiences and lessons learnt in the pandemic. Member Statesthat deployed pandemic influenza vaccines sharedlessons learnt in the deployment operationandhow thisexperiencewas used toupdate their national influenza pandemic preparedness and response plans (NIPPRP) includingthe national influenza pandemic vaccinedeployment plans (NIPVDP). Member States that did not deploy vaccines shared experience of containment ofInfluenza A/H1N1 (2009) pandemic without vaccine deployment and how lessons learnt in the pandemic helped updating the NIPPRP including the NIPVDP.
The other sessions were used to update the participants on the framework for preparedness and response for avian/pandemic influenza in the South-East Asia Region, need for seasonal influenza vaccine introduction and planning for strengthening influenza surveillance based onthe experience of vaccine-preventable disease surveillance network. In the final session, participants worked throughthree group work sessions that focused on rapid and efficient pandemic vaccine deployment, feasibility of seasonal influenza vaccine introduction in MemberStates and strengthening influenza surveillance in the Region. Participants made recommendations to Member States and to WHO in relation to these three areas focused in the group work.
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Report of Regional Workshop on Influenza Vaccines
1.Introduction
The WHO Regional Office for South East Asia (SEA) conducted a regional workshop on planning for the deployment of pandemic influenza vaccines in September 2009 in New Delhi. At the time of this workshop, the pandemic vaccine deployment was completely new to the Region. Hence, this workshop was primarily intended to facilitate gaining knowledge to develop National Influenza Pandemic Vaccine Deployment Plans (NIPVDP), define actions and responsibilities for delivering the vaccine in seven days to all distribution points once it would be available in the pandemic.
Despite uncertainties regarding the availability and adequacy of vaccines and funding for vaccines and operational costs, Member States deployed pandemic vaccines with a varying degree of success. In this process, they encountered a multitude of challenges and barriers to implementation. Theresponse to the influenza A/H1N1(2009) pandemicdemonstrated that due to complexities related to key requirements of delivering vaccines to countries such as delayed planning for vaccine deployment, difficulties pertinent to registration or authorization for use, issues related to custom clearance or delivering vaccines to vaccine centres, the vaccine deployment process was hampered. Given the rapid spread ofa pandemic, these delays couldimpact on the effectiveness of pandemic vaccines in delivering its ultimate objective. Therefore, based on the past experience, the need for reviewing pandemic response including vaccine deployment andupdating NIPVDP within the overall National Influenza Pandemic Preparedness and Response Plans (NIPPRP) has been elaborated in recommendations of several regional meetings.
A regional workshop on pandemic and seasonal influenza has been viewed as the best way to achieve this objective. Such a regional workshop enables reviewingthe degree to which pandemic vaccines were utilized in Member States, identifying barriers to vaccine deployment, comparing vaccine utilization rates across countries, being aware of different vaccine delivery methodologies used, listening to successes and failures in vaccine deployment in Member States in the Region, interacting with each other and learning from each other’s shared experience. These lessons could be utilized for effective planning in optimizing vaccine deployment in a future pandemic in the Region.Further updates on seasonal influenza vaccines and discussions with country managers facilitate looking into country perspectives of the necessity and feasibility of introduction of seasonal vaccines in Member States.The possibility of introducing seasonal influenza vaccines in the Region will offer a ray of hope for better preparedness for future pandemics by sustaining theregional manufacturing capacity of influenza (seasonal/pandemic) vaccines.
1.1General objective of the workshop
The general objective of the workshop was to strengthen efficient deployment of pandemic influenza vaccines and introduction of seasonal influenza vaccines in Member States of the South-East Asia Region.
1.2Specific objectives of the workshop
The specific objectives of the workshop were:
To review deployment of pandemic influenza vaccines by Member States during the Influenza A/H1N1 (2009) pandemic;
To identify mechanisms to further strengthen National Influenza Pandemic Vaccine Deployment Plans and incorporate them into the National Influenza Pandemic Preparedness and Response Plans;
To review the feasibility of introducing seasonal influenza vaccines in Member States of the South-East Asia Region
The regional workshop was attended by participants from 10 out of 11 Member States representing theirnational programmes of immunization and programmes ofpandemic influenza preparedness and response. In addition, stafffrom all the WHO country officesinvolved inEPI andpandemicinfluenzapreparedness andresponsealso participated in the workshop. The list of participants is available in Annex 1 and the detailed programme is given in the Annex 2.The Regional Director,Dr.Samlee Plianbangchang, inaugurated the workshop. In his address, the Regional Director highlighted the usefulness of the regional workshop as a platform for sharing individual country experiences in pandemic vaccine deployment in 2009 with a view to developing effective and comprehensive planning for vaccine deployment in a future pandemic within the overall NIPPRP. He also highlighted the appropriateness of using the regional forum to discuss the feasibility of introducing seasonal influenza vaccines in the Region. He invited participants to study the Thailand experience in this regard.Dr. Shashi Khare, head of the Department of polio laboratory of the National Institute of Communicable Diseases of the Ministry of Health and Family Welfare, Government of India, chaired the meeting. Dr.Soe Lwin Nyein, Director, Central Epidemiology Unit, Department of Health, Myanmar, was the co-chair while Dr. Aishath Thimna Latheef public health Programme Manager, Centre for Community Health and Disease Control of the Maldivian Ministry of Health acted as the rapporteur.
2.Proceedings of the regional workshop
2.1 Session I:Pandemic vaccine deployment
The session started with a presentation on “Pandemic Influenza vaccines: Lessons learnt in the 2009 pandemic” by Dr Wengqing Zhang, WHO HQ. Dr Zhang highlighted that among a multitude of challenges, early detection of the pandemic virus, sharing candidate vaccine virus, rapid development of a vaccine and ensuring its availability were the key challenges at the global level.Dr Zhang also highlighted the factors that worked well and those that did not work as anticipated in the pandemic vaccine deployment in 2009. She presented an outline of activities that should be taken into consideration in formulating an effective and efficient pandemic vaccine deployment in future.The suggestedactivities includedearly detection of novel viruses with pandemic potential,optimization of donor and candidate influenza vaccine viruses, improving vaccine antigen standardization(potency testing),improving vaccine production capacity and formulating policies and guidelines to increase the demand of seasonalinfluenza vaccine use with a view to sustainingcurrent global influenza vaccine manufacturing capacity andincreasinginvestments to expand it.
Dr. Nihal Abeysinghe, Regional Adviser, Vaccine Preventable Diseases,WHO Regional Office for SEA presented the regional perspective of the pandemicvaccine deployment in the 2009 influenza A/H1N1 pandemic. He emphasized that Member States in the Region had deployed pandemic vaccines post-peak of the first wave when there was a low demand. However, according to him 24.4 million doses had been deployed in eight countries of the Region. India and Thailand had procured vaccines from their national budgets. Among the countries that had been supplied pandemic vaccines by WHO, the utilization rate was 51%.Dr. Abeysinghe shared the key factors at the country level that facilitated successful vaccine deployment in the Region.Similarly, he shared with the participants the challenges faced by MemberStates and the WHO Regional Office in the deployment operation. He alsoexplained that there were seven manufacturers of pandemic influenza vaccines with an adequate manufacturing capacity in the Region and there isa regional need for sustaining this capacityto respond to another influenza pandemic in the future.In conclusion, he presented the regional recommendations issued by WHO in the post-pandemic period and activities of the Immunization and Vaccine Department planned on the basis of regional recommendations.
The next two segments of this session were allocated to country presentations.The first segment was for Member States that deployed pandemic vaccines while the second was forMember States that did not. In the first segment, Bangladesh, Bhutan, DPR Korea, India, Maldives, SriLanka, Thailand and Timor-Leste shared lessons learnt and explained how they used this experience to update their NIPPRP including NIPVDP.
Though Bangladesh‘s overall usage rate of pandemic vaccine was 74.3%, it was as low as 53% in the first phase due to the receipt of close expiry date vaccines and some misconceptions regarding pandemic vaccines. They had encountered issues such as delays in receiving vaccines, receiving vaccines with close expiry dates, receiving two types of vaccines in the two phases, operational problems associated with using the vaccines supplied with two containers containing antigen and liquid adjuvant during the pandemic vaccine deployment. Collaborative actions of the Department of Disease Control, Institute of Epidemiology Disease Control and Research (IEDCR) and the Expanded Programme of Immunization (EPI) enabled timely decision making regarding vaccine deployment while the experience of the EPI in conducting mass scale vaccination campaignscontributed immensely to the operational success. The communication with the media was effectively carried out by the Ministry of Health at the national level, health administrators at the local level and the field staffat the inter-personal level. Healthcare providers at all levels were given quality orientation with special focus on the private sector workers for whom micro-plans were prepared. Management of finances received from different sources, maintenance of law and order at vaccination centres due to high demand from non-priority groups by involving law enforcement authorities were highlighted as key challenges. The presentation underscored that despite these challenges, the successful pandemic vaccine deployment reflected the trust of Bangladeshi people on their national immunization programme. The strong communication between policy makers and implementors, establishment of a technical and scientific committee to oversee the deploymentand a 24- hour national monitoring cellwere reported ascontributory causes for success.
Bhutan’s reported utilization rate of pandemic vaccines was 91%. Bhutan highlighted that there were delays in finalizing the NIPVDP in consultation with WHO, signing the agreement with WHO to receive vaccines and receiving relevant documents from WHO for obtaining temporary registration from the National Regulatory Authority (NRA).Having to deploy vaccines parallel to the human papiloma virus(HPV)vaccination campaign, not having a specific budget for emergency use such as the pandemic vaccine deployment, the high demandof pandemic vaccines from non-priority groups, practical difficulties in close supervision and monitoring vaccine deployment, training health workers especially those who were without adequate competencies and technical knowledge in remote areas, finding competent trainers for training and fulfilling communication needs were seen as key challenges to implementing the pandemic vaccine deployment. The communication needs revolved around dispelling negative public perceptions on safety and efficacy of pandemic vaccines. Overall, the experience was a learning curve for Bhutan to face ad-hoc vaccination campaigns such as the pandemic vaccine deployment and Bhutan intends to update the NIPVDP in the future.
In the Democratic People’s Republic of Korea (DPRKorea), the overall utilization of pandemic vaccine was 70%. This was low compared to the coverage standards in DPRKorea for routine EPI vaccines.The low coverage is explained by the decreased felt need of vaccines by the general public given the phase of the pandemic in which vaccines were available in the country. There was a delay in receiving vaccines. The vaccines were received when the pandemic was contained resulting in low acceptance of vaccine. However, among the factors that contributedto a successful pandemic vaccine deployment, high political commitment,the strongsystem of incident command and control, early decision making, specific planning of vaccine deployment and close collaboration with other government agencies, the network offamily doctors andactiverole of the community in activitymonitoring wereviewed as exemplaryin DPRKorea.
In India, 1.5 million doses of pandemic influenza vaccines were procured by the national government. The target group for vaccination was all health-care workers in all states. The overall utilization rate was 76%.Aunique feature was that all states prepared model district pandemic vaccine deployment plans and established district task forces to oversee the implementation. Strong political commitment,quickdecision makingby the team constitutedby the centre ,fast track execution of all procedures by thetask force under the chairmanship of the health secretary, execution and coordination of the operationby the Director/Emergency Medical Relief (EMR) and establishment of state monitoring committees enabled rapid and efficient vaccine deployment. As the sole target group for vaccination was healthcare workers, there was no acute shortage of human resources for the deployment of vaccines. As influenza was not seen as a priority, there was a low acceptance as well as resistance tovaccine deployment in some areas. The less virulent nature of the pandemic virus, overlapping with the pulse polio programme, waiting for the locally made intra-nasal pandemic influenza vaccines were some factors that affected an effective pandemic influenza vaccine deployment.Augmenting quality and quantity of human resources required for a pandemic vaccine deployment, efforts for increasing community demands of vaccines, addressing programmatic issues, improving monitoring and supervision, immunization reviews as was done for polio and increasing indigenous pandemic influenza vaccine manufacturingwere viewed as key areasfor India to address in the future in terms of preparedness for a future pandemic vaccine deployment.
In Maldives, 47410 doses of vaccines belonging to three types of pandemic influenza vaccines from three different sources were deployed.There was a delay in receiving the first shipment of vaccine.It is noteworthy that the Maldivian government, with the direct involvement of the finance ministry, identified an emergency fund for the pandemic and its contribution in the form of immediate release of US $ 2.3 million was highly significant for vaccine deployment. High political commitment, not depending entirely on the stock supplied by WHO, role of the technical advisory committee, fast-track registration of vaccines by the NRA, contribution of the Maldivian police and National Defence Force in supply of additional human resources, and establishment of immunization centres by the Disaster Management Centre were key factors for an effective vaccine deployment. While front-line health workers were engaged in the deployment operation, quick mobilization of medical personnel of the Maldivian National Defence Force, volunteers and organizing rapid orientation covered the gaps in human resourcesto rapidly deploypandemic vaccines.Intersectoral committees acted as the main forum for “between-agency” communication while there was a designated focal point in each atoll for communication with the central level. A single media focal point was used for directly disseminating constant updates on the pandemic and vaccine deployment.Based on the experience of the pandemic, Maldives has already updated its NIPVDP andintends to establish a quarantine facility and a National Influenza Centre (NIC).